U.S. budget impact analysis of biosimilar versus originator intravenous rituximab for the treatment of non-Hodgkin lymphoma (NHL), chronic lymphocytic leukemia (CLL), rheumatoid arthritis (RA), granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA).

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e18820-e18820
Author(s):  
Elizabeth James ◽  
Holly Trautman ◽  
Ali McBride ◽  
Azhar Choudhry ◽  
Stephen Thompson
Keyword(s):  
B Cell ◽  
Impact Analysis ◽  
Budget Impact ◽  
Drug Acquisition ◽  
B Cell Lymphoma ◽  
Economic Benefits ◽  
Lymphocytic Leukemia ◽  
Sensitivity Analyses ◽  
Cost Share ◽  
The Impact

e18820 Background: Rituximab-abbs is an anti-CD20 monoclonal antibody and an important immuno-oncology agent for the treatment of B-cell malignancies NHL (diffuse large B-cell lymphoma [DLBCL] and follicular lymphoma [FL]) and CLL. It is also indicated for patients with RA, GPA, and MPA. Rituximab-abbs was the first rituximab biosimilar approved in the US and is expected to reduce drug acquisition costs. This budget impact model (BIM) estimated the impact of replacing a share of originator rituximab (IV-R-REF) use with rituximab-abbs (IV-R-BIOSIM) for NHL (DLBCL and FL), CLL, RA, GPA, and MPA. The objective was to project incremental annual cost differences between IV-R-BIOSIM and IV-R-REF for a hypothetical 1-million-member US healthcare insured (Medicare) population. Methods: An illustrative BIM estimated changes in 1-year drug and administration costs for an increased IV-R-BIOSIM uptake from 17.5% to 22.0%. Values for epidemiology, market share distribution, drug dosing, administration, and costs were derived from scientific literature, product labels, and publicly available cost resources. Dosing was based on a mean patient body surface area of 1.8 m2. Annual dose counts per patient were: 10 untreated FL with maintenance; 8 untreated FL (without maintenance), relapsed/refractory FL, or untreated DLBCL; 6 CLL, and 4 for RA, GPA, or MPA. All treatments were assumed to infuse over 3 hours. Drug acquisition and administration costs were from 2020 Average Sales Price pricing file and Centers for Medicare and Medicaid Services Physician Fee Schedule. Patient cost share was based on 2020 Medicare Part B 20% cost-share for office visits and drug products. Univariate sensitivity analyses were conducted. A scenario analysis was performed to project 2-year costs for extended FL maintenance treatment. Results: Estimated total annual plan incremental savings for a 1-million-member payer after the utilization shift were $312,379, equating to $0.31 per enrolled member per year (PMPY). Per-patient incremental drug cost savings with IV-R-BIOSIM for 1-year were $5,474–$12,924 (Table). The model was most sensitive to IV-R-REF cost and proportion of patients with RA. Conclusions: This analysis estimated annual savings of over $310,000 ($0.31 PMPY) for a 1-million-member US payer following a 4.5% utilization shift from IV-R-REF to IV-R-BIOSIM, demonstrating that IV-R-BIOSIM may confer considerable economic benefits vs originator rituximab.[Table: see text]

U.S. budget impact analysis of an intravenousrituximab biosimilar versus subcutaneous rituximab for the treatment of non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia (CLL).

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e18821-e18821
Author(s):  
Elizabeth James ◽  
Holly Trautman ◽  
Ali McBride ◽  
Azhar Choudhry ◽  
Stephen Thompson
Keyword(s):  
Impact Analysis ◽  
Budget Impact ◽  
Drug Acquisition ◽  
Subcutaneous Administration ◽  
B Cell Lymphoma ◽  
Economic Benefits ◽  
Lymphocytic Leukemia ◽  
Sensitivity Analyses ◽  
Cost Share ◽  
One Year

e18821 Background: Rituximab-abbs is a CD20-directed monoclonal antibody and the first rituximab biosimilar approved in the US, expected to significantly reduce drug acquisition costs. This budget impact model (BIM) estimated budgetary impact of replacing a proportion of rituximab/hyaluronidase human subcutaneous injection (SC-R) utilization for NHL (diffuse large B-cell lymphoma [DLBCL], follicular lymphoma [FL]) and CLL with rituximab-abbs (IV-R-BIOSIM). The objective was to project incremental cost differences between IV-R-BIOSIM and SC-R over one year for a hypothetical 5-million-member US healthcare insured (Medicare) population. Methods: An illustrative BIM was developed to estimate 1-year drug and administration costs for a one-quarter shift in SC-R market utilization to IV-R-BIOSIM, with equal efficacy and safety assumed. Values for epidemiology, market share, drug dosing, administration, and costs were derived from scientific literature, product labels, and publicly available cost resources. Infused rituximab (IV-R) dosing assumed a mean body surface area (BSA) of 1.8m2. Annual dose counts of IV-R-BIOSIM or SC-R per patient were: 10 untreated FL with maintenance; 8 untreated FL (without maintenance), relapsed/refractory FL, or untreated DLBCL; 6 CLL. IV-R infusion duration was 3 hours. Drug acquisition and infusion/subcutaneous administration costs were from 2020 Average Sales Price pricing file and Centers for Medicare and Medicaid Services Physician Fee Schedule. SC-R costs included an initial IV-R originator dose. Patient cost share was based on 2020 Medicare Part B 20% cost-share for office visits and drugs. Univariate sensitivity analyses were conducted. A scenario analysis used 2-year dosing to estimate costs for further FL maintenance treatment. Results: For a 5-million-member insured population, an estimated 972 patients would receive rituximab for NHL or CLL; 49 would receive SC-R. Estimated total incremental savings for one year for a 13-patient shift from SC-R to IV-R-BIOSIM were $57,864, equating to $0.02 per enrolled member per year (PMPY). Per-patient incremental annual savings with IV-R-BIOSIM for one year ranged between $2,359–$8,186 (Table). The model was most sensitive to low or high BSA dosing and proportion of patients with CLL. Conclusions: This BIM estimated annual savings of over $57,000 ($0.02 PMPY) for a 5-million-member US payer following a 25% shift of current SC-R use to IV-R-BIOSIM. These findings demonstrate the potential economic benefits of IV-R-BIOSIM vs SC-R that may result in expanded access to rituximab therapy.[Table: see text]

U.S. budget impactanalysis of body surface area (BSA)dosing for a rituximab biosimilar vsflat-fixed-dosing for subcutaneous rituximab in non-Hodgkin lymphoma (NHL)and chronic lymphocytic leukemia (CLL).

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e18822-e18822
Author(s):  
Stephen Thompson ◽  
Holly Trautman ◽  
Ali McBride ◽  
Azhar Choudhry ◽  
Elizabeth James
Keyword(s):  
Drug Acquisition ◽  
B Cell Lymphoma ◽  
Economic Benefits ◽  
Lymphocytic Leukemia ◽  
Office Visits ◽  
Annual Dose ◽  
Cost Share ◽  
Drug Dosing ◽  
Non Hodgkin Lymphoma ◽  
Medicare Part B

e18822 Background: The first rituximab biosimilar approved in the US, rituximab-abbs, is a CD20-directed monoclonal antibody that is expected to significantly reduce drug acquisition costs. This economic analysis evaluated budgetary impact of BSA-based rituximab-abbs (IV-R-BIOSIM) vs flat-fixed rituximab/hyaluronidase human subcutaneous injection (SC-R) dosing in NHL (diffuse large B-cell lymphoma [DLBCL], follicular lymphoma [FL]) and CLL. The objective was to project incremental cost differences per patient between IV-R-BIOSIM and SC-R from a US healthcare insured (Medicare) population. Methods: An illustrative BIM estimated 1-year costs for IV-R-BIOSIM and SC-R. The model assumed equal efficacy and safety between products. Values for epidemiology, market share distribution, drug dosing, administration, and costs were derived from scientific literature, product labels, and publicly available cost resources. Costs for the first infused rituximab (IV-R) dose were excluded for appropriate comparison. IV-R-BIOSIM doses used BSAs of 1.6 m2, 1.8 m2, infusion duration was 3 hours. Annual dose counts of IV-R-BIOSIM or SC-R were: 9 untreated FL with maintenance; 7 untreated FL (without maintenance), relapsed/refractory FL, or untreated DLBCL; 5 CLL. Drug acquisition and administration costs were from 2020 Average Sales Price pricing file and Centers for Medicare and Medicaid Services Physician Fee Schedule. Patient cost share was 2020 Medicare Part B 20% cost-share for office visits and drugs. A scenario analysis was also performed to estimate FL maintenance costs for 2-year dosing. Results: Estimated 1-year savings with IV-R-BIOSIM for 1.8 m2 BSA dosing were $1,067–$6,893 with variability between indications (Table). For 1.6 m2 BSA dosing, estimated 1-year savings with IV-R-BIOSIM were $3,819–$10,856. Estimated 2-year savings with IV-R-BIOSIM for FL maintenance dosing were $9,191 for 1.8 m2 BSA dosing and $14,475 for 1.6 m2 BSA dosing. Savings of up to $1,900 were seen for higher-than-average BSA dosing, regardless of regimen. Conclusions: These findings demonstrate the potential economic benefits of replacing a proportion of SC-R use with BSA-based IV-R-BIOSIM from a US payer perspective, especially when lower BSA dosing is used. Savings are driven by drug costs and may increase with IV-R-BIOSIM as patient BSA decreases due to static costs with SC-R doses. These data also suggest that drug wastage may occur with SC-R in lower BSA patients.[Table: see text]

Association between the proliferative rate of neoplastic B cells, their maturation stage, and underlying cytogenetic abnormalities in B-cell chronic lymphoproliferative disorders: analysis of a series of 432 patients

Blood ◽  
2008 ◽  
Vol 111 (10) ◽  
pp. 5130-5141 ◽  
Author(s):  
Sandra Quijano ◽  
Antonio López ◽  
Ana Rasillo ◽  
Susana Barrena ◽  
Maria Luz Sánchez ◽  
...  
Keyword(s):  
B Cells ◽  
B Cell ◽  
Cell Lymphoma ◽  
B Cell Lymphoma ◽  
Lymphoproliferative Disorders ◽  
Lymphocytic Leukemia ◽  
Maturation Stage ◽  
Cytogenetic Abnormalities ◽  
M Phase ◽  
The Impact

Abstract Limited knowledge exists about the impact of specific genetic abnormalities on the proliferation of neoplastic B cells from chronic lymphoproliferative disorders (B-CLPDs). Here we analyze the impact of cytogenetic abnormalities on the proliferation of neoplastic B cells in 432 B-CLPD patients, grouped according to diagnosis and site of sampling, versus their normal counterparts. Overall, proliferation of neoplastic B cells highly varied among the different B-CLPD subtypes, the greatest numbers of proliferating cells being identified in diffuse large B-cell lymphoma (DLBCL) and Burkitt lymphoma (BL). Compared with normal B cells, neoplastic B-CLPD cells showed significantly increased S + G2/M-phase values in mantle cell lymphoma (MCL), B-chronic lymphocytic leukemia (B-CLL), BL, and some DLBCL cases. Conversely, decreased proliferation was observed in follicular lymphoma, lymphoplasmacytic lymphoma/Waldenström macroglobulinemia (LPL/WM), and some DLBCL patients; hairy cell leukemia, splenic marginal zone, and MALT-lymphoma patients showed S + G2/M phase values similar to normal mature B lymphocytes from LN. Interestingly, in B-CLL and MCL significantly higher percentages of S + G2/M cells were detected in BM versus PB and in LN versus BM and PB samples, respectively. In turn, presence of 14q32.3 gene rearrangements and DNA aneuploidy, was associated with a higher percentage of S + G2/M-phase cells among LPL/WM and B-CLL cases, respectively.

Budget impact analysis of the HIV/AIDS treatment on a national scale: a study from the Vietnam Social Security perspective

MedPharmRes ◽  
2021 ◽  
Vol 5 (1) ◽  
pp. 8-14
Author(s):  
Nhac-Vu Hoang-Thy ◽  
Thi-Ngoc-Van Tran ◽  
Thi-Thu-Ha Do
Keyword(s):  
Social Security ◽  
Impact Analysis ◽  
Budget Impact ◽  
Social Health Insurance ◽  
Treatment Goal ◽  
Sensitivity Analyses ◽  
National Scale ◽  
Mean Values ◽  
The Impact ◽  
Hiv Aids

Objectives: To analyze the budget impact of the HIV/AIDS treatment on a national scale, from the Vietnam Social Security (VSS) perspective. Methods: A model with a 5-year time horizon was developed. The total first year direct medical cost (DMC) and its cost components were estimated for HIV-infected populations each year. Budget impact was described through the proportion of the DMC over the social health insurance (SHI) budget. A scenario analysis was conducted with four settings of different proportions of members and coverage levels of the SHI. All costs were converted to 2020 US dollars. 1-way sensitivity analyses were conducted with variations of mean values in a range of ±25%. Results: The total DMC was estimated at $1.8M (10,000 cases) to treat all new infections and $27.7M (150,000 cases) to reach the treatment goal of the Ministry of Health (MOH) in 2020. The total DMC accounted for 0.6% of the SHI budget for the year 2020 to meet the treatment goal. The costs of CD4-count test and fully suppressive regimen containing Tenofovir Disoproxil Fumarate (TDF) were identified as key cost drivers. The proportion of the total DMC over the SHI budget among different scenarios did not vary significantly. Conclusion: This is the first-ever study analyzing the budget impact of the HIV/AIDS treatment on a national scale, from the VSS perspective. The results showed that the cost of HIV/AIDS care was economical and the impact on the SHI budget was reasonable. Findings could be used to notify the MOH to allocate domestic resources and to optimize the current programs.

scholarly journals Budget Impact Analysis of Biosimilar Products in Spain in the Period 2009–2019

2021 ◽  
Vol 14 (4) ◽  
pp. 348
Author(s):  
Manuel García-Goñi ◽  
Isabel Río-Álvarez ◽  
David Carcedo ◽  
Alba Villacampa
Keyword(s):  
Impact Analysis ◽  
Budget Impact ◽  
Public Procurement ◽  
National Health System ◽  
Drug Acquisition ◽  
Sensitivity Analyses ◽  
Full Potential ◽  
Great Opportunity ◽  
Pharmaceutical Spending ◽  
Uptake Data

Since the first biosimilar medicine, Omnitrope® (active substance somatropin) was approved in 2006, 53 biosimilars have been authorized in Spain. We estimate the budget impact of biosimilars in Spain from the perspective of the National Health System (NHS) over the period between 2009 and 2019. Drug acquisition costs considering commercial discounts at public procurement procedures (hospital tenders) and uptake data for both originator and biosimilar as actual units consumed by the NHS were the two variables considered. Two scenarios were compared: a scenario where no biosimilars are available and the biosimilar scenario where biosimilars are effectively marketed. All molecules exposed to biosimilar competition during this period were included in the analysis. The robustness of the model was tested by conducting multiple sensitivity analyses. From the payer perspective, it is estimated that the savings produced by the adoption of biosimilars would reach EUR 2306 million over 11 years corresponding to the cumulative savings from all biosimilars. Three molecules (infliximab, somatropin and epoetin) account for 60% of the savings. This study provides the first estimation of the financial impact of biosimilars in Spain, considering both the effect of discounts that manufacturers give to hospitals and the growing market share of biosimilars. We estimate that in our last year of data, 2019, the savings derived from the use of biosimilars relative total pharmaceutical spending in Spain is 3.92%. Although more research is needed, our evidence supports the case that biosimilars represent a great opportunity to the sustainability of the NHS through rationalizing pharmaceutical spending and that the full potential of biosimilar-savings has not been achieved yet, as there is a high variability in biosimilar uptake across autonomous regions.

The Impact of a Potential Public/Private Initiative on a Defined Region of the South Suburban Chicago Metropolitan Area

2019 ◽  
pp. 14-32
Keyword(s):  
Supply Chain ◽  
Economic Impact ◽  
Impact Analysis ◽  
Census Data ◽  
Economic Benefits ◽  
Local Economy ◽  
Market Area ◽  
State And Local ◽  
The University ◽  
The Impact

The university is considered one of the engines of growth in a local economy or its market area, since its direct contributions consist of 1) employment of faculty and staff, 2) services to students, and supply chain links vendors, all of which define the University’s Market area. Indirect contributions consist of those agents associated with the university in terms of community and civic events. Each of these activities represent economic benefits to their host communities and can be classified as the economic impact a university has on its local economy and whose spatial market area includes each of the above agents. In addition are the critical links to the University, which can be considered part of its Demand and Supply chain. This paper contributes to the field of Public/Private Impact Analysis, which is used to substantiate the social and economic benefits of cooperating for economic resources. We use Census data on Output of Goods and Services, Labor Income on Salaries, Wages and Benefits, Indirect State and Local Taxes, Property Tax Revenue, Population, and Inter-Industry to measure economic impact (Implan, 2016).

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